Review Clinical Information

U.S. FDA Trial Overview

In the U.S. FDA clinical trial, the objective of this study was to see if the coflex device was safe and effective in patients with moderate to severe spinal stenosis and no instability (≤ Grade 1 spondylolisthesis).

Study Design:

322 patients studied (215 coflex, 107 fusion)

21 investigational locations

Follow up visits at 3, 12, 24, 36, 48 and 60 months

Conclusion:

The coflex device proved to be a viable alternative treatment option compared to pedicle screw fusion out to 5 years, and results showed that coflex patients performed as good as, if not better, in all clinical measurements.

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Are you a candidate?

Complete the questions below and then click the "Am I a Candidate?" button to see if you are a possible candidate for coflex® surgery, and learn more regarding specific indications for surgery with coflex® .

If unsure about the answers to these questions, please consult with your doctor about your condition. This is for educational purposes only and is not meant to replace a conversation with and an examination by a qualified physician.

Do you experience moderate to severe leg pain with or without back pain?

Yes

No

Have you tried at least 6 months of nonsurgical care such as physical therapy or medication, or are your symptoms getting progressively worse?

Yes

No

Has a physician indicated that you might need surgery at one or two levels in your lumbar spine?